Lumos Diagnostics Granted FDA CLIA Waiver for FebriDx
Key points
- FDA grants CLIA waiver for Lumos' flagship FebriDx point-of-care test
- Waiver follows 510(k) clearance for FebriDx
- Announcement triggers $20M placement by Lumos
Full summary
Lumos Diagnostics Holdings Limited (LDX) announced that the US Food and Drug Administration (FDA) has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the company's flagship point-of-care test, FebriDx, following its 510(k) clearance (K260787). The company became aware of the FDA correspondence regarding the CLIA waiver on the morning of Wednesday, 25 March 2026, before market open. Lumos immediately requested a trading halt to review the implications of the FDA correspondence, including any conditions or requirements, and to ensure it could provide full and complete disclosure to the market. After completing its internal review and approval process, Lumos released the announcement on the ASX Market Announcements Platform on Friday, 27 March 2026. The announcement of the CLIA waiver grant triggered a $20 million institutional placement by Lumos, which was substantially oversubscribed. The placement will be used to fund the commercialization of FebriDx and other growth initiatives.
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